Paravalvular leak occlusion device for self-expanding heart valves

ABSTRACT

An occluder device for occluding a gap between a medical device and adjacent body tissue includes a conformable body having a hollow interior, a leading end and a trailing end; and a port disposed at the trailing end of the body and in fluid communication with the interior of the body.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 14/096,427, filed Dec. 4, 2013, which is a continuation-in-partof U.S. patent application Ser. No. 13/797,513, filed Mar. 12, 2013, thedisclosures of which are hereby incorporated herein by reference.

BACKGROUND OF THE INVENTION

The present disclosure relates in general to heart valve replacementand, in particular, to collapsible prosthetic heart valves. Moreparticularly, the present disclosure relates to devices and methods forpositioning and sealing of collapsible prosthetic heart valves.

Prosthetic heart valves that are collapsible to a relatively smallcircumferential size can be delivered into a patient less invasivelythan valves that are not collapsible. For example, a collapsible valvemay be delivered into a patient via a tube-like delivery apparatus suchas a catheter, a trocar, a laparoscopic instrument, or the like. Thiscollapsibility can avoid the need for a more invasive procedure such asfull open-chest, open-heart surgery.

Collapsible prosthetic heart valves typically take the form of a valvestructure mounted on a stent. There are two types of stents on which thevalve structures are ordinarily mounted: a self-expanding stent or aballoon-expandable stent. To place such valves into a delivery apparatusand ultimately into a patient, the valve must first be collapsed orcrimped to reduce its circumferential size.

When a collapsed prosthetic valve has reached the desired implant sitein the patient (e.g., at or near the annulus of the patient's heartvalve that is to be replaced by the prosthetic valve), the prostheticvalve can be deployed or released from the delivery apparatus andre-expanded to full operating size. For balloon-expandable valves, thisgenerally involves releasing the entire valve, and then expanding aballoon positioned within the valve stent. For self-expanding valves, onthe other hand, the stent automatically expands as the sheath coveringthe valve is withdrawn.

SUMMARY OF THE INVENTION

In some embodiments, an occluder device for occluding a gap between amedical device and adjacent body tissue includes an expandable bodyhaving a first end and a second end, a fastener coupled to the first endof the body, and an expandable disk coupled to the second end of thebody.

In some embodiments, a method for occluding a gap between a prostheticheart valve and adjacent body tissue includes delivering an occluderinto the interior of the heart valve, the occluder having (i) anexpandable body, (ii) a fastener coupled to one end of the body, and(iii) an expandable disk coupled to another end of the body. Theoccluder is advanced through a cell of the heart valve to the outside ofthe heart valve. The fastener is coupled to one end of the prostheticheart valve and the expandable disk is coupled to the prosthetic heartvalve at a position spaced from the one end.

BRIEF DESCRIPTION OF THE DRAWINGS

Various embodiments of the present disclosure are described herein withreference to the drawings, wherein:

FIG. 1 is a side elevational view of a conventional prosthetic heartvalve;

FIG. 2 is a highly schematic cross-sectional view taken along line A-Aof FIG. 1 and showing the prosthetic heart valve disposed within anative valve annulus;

FIG. 3A is a side view of a conformable occluder in accordance with oneembodiment of the present disclosure;

FIG. 3B is a side view of the conformable occluder of FIG. 3A after ithas been stretched longitudinally;

FIG. 3C is a side view of a conformable occluder having a filler inaccordance with another embodiment of the present invention;

FIG. 3D is a side view of a conformable occluder having two fasteners inaccordance with another embodiment of the present invention;

FIGS. 4A-F illustrate the steps used to insert a conformable occluder toseal a prosthetic heart valve within a native valve annulus;

FIG. 5 is a highly schematic cross-sectional view showing a prostheticheart valve disposed within a native valve annulus along with aconformable occluder in its fully expanded state;

FIG. 6A is a side view of a conformable occluder in accordance withanother embodiment of the present disclosure;

FIGS. 6B-D are side, top and bottom views showing the use of theconformable occluder of FIG. 6A in vitro;

FIG. 7A is a side view of a conformable occluder in accordance withanother embodiment of the present disclosure;

FIGS. 7B-D are side, top and bottom views showing the use of theconformable occluder of FIG. 7A in vitro;

FIGS. 8A-D are side views of several additional embodiments of aconformable occluder;

FIG. 9 is a highly schematic cross-sectional view showing a prostheticheart valve disposed within a native valve annulus along with theconformable occluders of FIGS. 8A-C in their fully expanded states;

FIG. 10 is a side view illustrating the filling process of a conformableoccluder; and

FIGS. 11-18 illustrate several techniques for fixing occluders in placebetween a heart valve and a native valve leaflet.

DETAILED DESCRIPTION

Despite the various improvements that have been made to the collapsibleprosthetic heart valve delivery process, conventional devices sufferfrom some shortcomings. For example, with conventional self expandingvalves, clinical success of the valve is dependent on accuratedeployment and anchoring. Inaccurate deployment and anchoring of thevalve increases risks, such as those associated with valve migration,which may cause severe complications and possibly death due to theobstruction of the left ventricular outflow tract. Inaccurate deploymentand anchoring may also result in the leakage of blood between theimplanted heart valve and the native valve annulus, commonly referred toas paravalvular (otherwise known as perivalvular) leakage. This leakageenables blood flow from the aorta back into the left ventricle, reducingcardiac efficiency and putting a greater strain on the heart muscle.Additionally, calcification of the aortic valve may affect performanceand the interaction between the implanted valve and the calcified tissueis believed to be relevant to leakage, as will be outlined below.

Moreover, anatomical variations between patients may require removal ofa fully deployed heart valve from the patient if it appears that thevalve is not functioning properly. Removing a fully deployed heart valveincreases the length of the procedure and increases the risk ofinfection and/or damage to heart tissue. Thus, methods and devices aredesirable that would reduce the likelihood of removal. Methods anddevices are also desirable that would reduce the likelihood ofparavalvular leakage through gaps formed between the implanted heartvalve and patient tissue.

There therefore is a need for further improvements to the devices,systems, and methods for transcatheter delivery and positioning ofcollapsible prosthetic heart valves. Specifically, there is a need forfurther improvements to the devices, systems, and methods for accuratelyimplanting a prosthetic heart valve. Among other advantages, the presentdisclosure may address one or more of these needs.

Various embodiments of the present invention will now be described withreference to the appended drawings. It is to be appreciated that thesedrawings depict only some embodiments of the invention and are thereforenot to be considered limiting of its scope.

As used herein, the term “proximal,” when used in connection with aprosthetic heart valve, refers to the end of the heart valve closest tothe heart when the heart valve is implanted in a patient, whereas theterm “distal,” when used in connection with a prosthetic heart valve,refers to the end of the heart valve farthest from the heart when theheart valve is implanted in a patient. When used in connection withdevices for delivering a prosthetic heart valve or other medical deviceinto a patient, the terms “trailing” and “leading” are to be taken asrelative to the user of the delivery devices. “Trailing” is to beunderstood as relatively close to the user, and “leading” is to beunderstood as relatively farther away from the user. Also as usedherein, the terms “about,” “generally” and “substantially” are intendedto mean that slight deviations from absolute are included within thescope of the term so modified.

The leak occluders of the present invention may be used in connectionwith collapsible prosthetic heart valves. FIG. 1 shows one suchcollapsible stent-supported prosthetic heart valve 100 including a stent102 and a valve assembly 104 as known in the art. The prosthetic heartvalve 100 is designed to replace a native tricuspid valve of a patient,such as a native aortic valve. It should be noted that while theinventions herein are described predominately in connection with theiruse with a prosthetic aortic valve and a stent having a shape asillustrated in FIG. 1, the valve could be a bicuspid valve, such as themitral valve, and the stent could have different shapes, such as aflared or conical annulus section, a less-bulbous aortic section, andthe like, and a differently shaped transition section.

Prosthetic heart valve 100 will be described in more detail withreference to FIG. 1. Prosthetic heart valve 100 includes expandablestent 102 which may be formed from, for example, a shape memorymaterial, such as the nickel-titanium alloy known as “Nitinol” or othersuitable metals, and in particular, from those materials that arecapable of self-expansion. Stent 102 extends from proximal or annulusend 130 to a distal or aortic end 132, and includes annulus section 140adjacent proximal end 130, transition section 141 and aortic section 142adjacent distal end 132. Annulus section 140 has a relatively smallcross-section in the expanded condition, while aortic section 142 has arelatively large cross-section in the expanded condition. Preferably,annulus section 140 is in the form of a cylinder having a substantiallyconstant diameter along its length. Transition section 141 may taperoutwardly from annulus section 140 to aortic section 142. Each of thesections of stent 102 includes a plurality of struts 160 forming cells162 connected to one another in one or more annular rows around thestent. For example, as shown in FIG. 1, annulus section 140 may have twoannular rows of complete cells 162 and aortic section 142 and transitionsection 141 may each have one or more annular rows of partial cells 162.Cells 162 in aortic section 142 may be larger than cells 162 in annulussection 140. The larger cells in aortic section 142 better enableprosthetic valve 100 to be positioned in the native valve annuluswithout the stent structure interfering with blood flow to the coronaryarteries.

Stent 102 may also include a plurality of commissure features 166 forattaching the commissure between two adjacent leaflets to stent 102. Ascan be seen in FIG. 1, commissure features 166 may lie at theintersection of four cells 162, two of the cells being adjacent oneanother in the same annular row, and the other two cells being indifferent annular rows and lying in end-to-end relationship. Preferably,commissure features 166 are positioned entirely within annulus section140 or at the juncture of annulus section 140 and transition section141. Commissure features 166 may include one or more eyelets whichfacilitate the suturing of the leaflet commissure to the stent.

Stent 102 may include one or more retaining elements 168 at distal end132 thereof, retaining elements 168 being sized and shaped to cooperatewith female retaining structures (not shown) provided on the deploymentdevice. The engagement of retaining elements 168 with the femaleretaining structures on the deployment device helps maintain prostheticheart valve 100 in assembled relationship with the deployment device,minimizes longitudinal movement of the prosthetic heart valve relativeto the deployment device during unsheathing or resheathing procedures,and helps prevent rotation of the prosthetic heart valve relative to thedeployment device as the deployment device is advanced to the targetlocation and the heart valve deployed.

Prosthetic heart valve 100 includes valve assembly 104 preferablypositioned in annulus section 140 of the stent 102 and secured to thestent. Valve assembly 104 includes cuff 176 and a plurality of leaflets178 which collectively function as a one-way valve by coapting with oneanother. As a prosthetic aortic valve, valve 100 has three leaflets 178,as well as three commissure features 166. However, it will beappreciated that other prosthetic heart valves with which the leakoccluders of the present invention may be used may have a greater orlesser number of leaflets 178 and commissure features 166.

Although cuff 176 is shown in FIG. 1 as being disposed on the luminal orinner surface of annulus section 140, it is contemplated that cuff 176may be disposed on the abluminal or outer surface of annulus section 140or may cover all or part of either or both of the luminal and abluminalsurfaces. Both cuff 176 and leaflets 178 may be wholly or partly formedof any suitable biological material or polymer such as, for example,polytetrafluoroethylene (PTFE), ultra-high molecular weight polyethylene(UHMWPE), silicone, or polyethylene terephthalate (PET) or combinationsthereof.

Prosthetic heart valve 100 may be used to replace a native aortic valve,a surgical heart valve or a heart valve that has undergone a surgicalprocedure. The prosthetic heart valve may be delivered to the desiredsite (e.g., near the native aortic annulus) using any suitable deliverydevice. During delivery, prosthetic heart valve 100 is disposed insidethe delivery device in the collapsed condition. The delivery device maybe introduced into a patient using a transfemoral, transapical,transseptal or any other percutaneous approach. Once the delivery devicehas reached the target site, the user may deploy prosthetic heart valve100. Upon deployment, prosthetic heart valve 100 expands so that annulussection 140 is in secure engagement within the native aortic annulus.When prosthetic heart valve 100 is properly positioned inside the heart,it works as a one-way valve, allowing blood to flow from the leftventricle of the heart to the aorta, and preventing blood from flowingin the opposite direction.

Problems may be encountered when implanting prosthetic heart valve 100.For example, in certain procedures, collapsible valves may be implantedin a native valve annulus without first resecting the native valveleaflets. The collapsible valves may have critical clinical issuesbecause of the nature of the stenotic leaflets that are left in place.Additionally, patients with uneven calcification, bi-cuspid aortic valvedisease, and/or valve insufficiency cannot be treated well, if at all,with the current collapsible valve designs. Similar issues may beencountered due to undersizing, improper placement or seating of a heartvalve or off-axis placement within the patient anatomy.

The reliance on unevenly calcified leaflets for proper valve placementand seating could lead to several problems, such as paravalvular leakage(PV leak), which can have severe adverse clinical outcomes. To reducethese adverse events, the optimal valve would anchor adequately and sealwithout the need for excessive radial force that could harm nearbyanatomy and physiology.

FIG. 2 is a highly schematic cross-sectional illustration of prostheticheart valve 100 disposed within native valve annulus 250. As seen in thefigure, annulus section 140 of the stent 102 has a substantiallycircular cross-section which is disposed within the non-circular nativevalve annulus 250. At certain locations around the perimeter of heartvalve 100, crescent-shaped gaps 200 form between heart valve 100 andnative valve annulus 250. Blood flowing through these gaps and pastvalve assembly 104 of prosthetic heart valve 100 can cause regurgitationand other inefficiencies which reduce cardiac performance. Such improperfitment may be due to suboptimal native valve annulus geometry due, forexample, to calcification of native valve annulus 250 or to unresectednative leaflets.

FIGS. 3A and 3B illustrate one embodiment of conformable occluder 300intended to fill irregularities between heart valve 100 and native valveannulus 250 shown in FIG. 2. As will be described in more detail below,conformable occluder 300 allows for superior sealing between theperimeter of heart valve 100 and native valve annulus 250 whileaffording a low radial outward force. FIG. 3A shows conformable occluder300 in a relaxed and expanded configuration, while FIG. 3B showsconformable occluder 300 in a stretched and partially elongatedconfiguration. Conformable occluder 300 has a leading end 302 and atrailing end 304, and may generally include body 310, fastener 320, anddisk 330.

Body 310 may be a metallic structure that may be longitudinallystretched in the direction of arrows S from the relaxed condition shownin FIG. 3A to the stretched condition shown in FIG. 3B. In the relaxedcondition, body 310 may have a cross-section that is greater in sizethan it is in the stretched condition. Thus, body 310 of conformableoccluder 300 may be flexible and capable of contracting in the radialdirection when a force is applied thereto to conform to the shape of theannulus in which it will be implanted. Moreover, the ability of body 310to longitudinally stretch in the direction of arrows S will enable theoccluder to be delivered through a small diameter catheter and to besecured between two attachment points as will be seen below withreference to FIGS. 4A-4F.

Occluder 300 may be formed from a tubular section of braided fabriccomprising a plurality of braided strands. The strands forming the braidmay have a predetermined relative orientation with respect to oneanother (e.g., a helical braid). The ends of the strands may be locatedat leading end 302 and trailing end 304, and maybe affixed to oneanother to prevent unraveling by any suitable means such as soldering,brazing, welding, gluing, tying, or clamping. Moreover, occluder 300 maycomprise a plurality of layers of braided fabric and/or other occludingmaterial (e.g., see filler 345 in FIG. 3C) such that occluder 300 iscapable of at least partially inhibiting blood flow therethrough inorder to facilitate the formation of thrombus and epithelialization.

Occluder 300 may be formed, for example, of a shape-memory material, ofa super-elastic material, of a bio-compatible polymer, or of anothermaterial that is capable of collapsing and expanding. In the embodimentsdepicted in FIGS. 3A-3C, occluder 300 comprises a braided metal fabricthat is both resilient and capable of heat treatment to substantiallyset a desired preset shape (e.g., the relaxed configuration shown inFIG. 3A). One class of materials which meets these qualifications isshape memory alloys. One example of a shape memory alloy is Nitinol. Itis also understood that occluder 300 may comprise various materialsother than Nitinol that have elastic and/or memory properties, such asspring stainless steel, trade named alloys such as Elgiloy® andHastelloy®, CoCrNi alloys (e.g., trade name Phynox), MP35N®, CoCrMoalloys, a mixture of metal and polymer fibers or a braided fabric.Occluder 300 may further include a coating such as polymer sheets,tissue or collagen. Depending on the individual material selected,strand diameter, number of strands, and pitch may be altered to achievethe desired properties of occluder 300.

As further described below, body 310 may be collapsed during deliveryinto the patient and re-expanded after delivery to occlude gaps betweena prosthetic heart valve and the native valve annulus to one side of thevalve. While body 310 is shown in FIG. 3A as having an ellipticallongitudinal cross-section in the expanded condition, it will beunderstood that the body may be constructed with various shapes and/orsizes. For example, body 310 may have a circular, oval, polygonal,square, diamond, triangular or other shape in longitudinal cross-sectionwhen expanded. Body 310 may also include two or more segments.Additionally, body 310 may be formed of multiple layers of braid todecrease occlusion time.

Body 310 may be connected to fastener 320 at leading end 302 ofconformable occluder 300. Fastener 320 may be formed of a suture,polymeric fiber, metallic filament, such as a flexible strandedstainless steel cable or loop of nitinol wire, or other suitablematerial, and may be configured to secure conformable occluder 300 toprosthetic heart valve 100 as will be described in greater detail below.Though fastener 320 is shown in FIG. 3A as a loop, it will be understoodthat a simple hook, clasp or other similar structure capable ofgrasping, clipping, or hooking conformable occluder 300 to a strut 160of prosthetic heart valve 100 may be used.

Body 310 may further be coupled to disk 330 at trailing end 304 ofconformable occluder 300. In the depicted embodiment, body 310 iscoupled to disk 330 by a small diameter waist. Disk 330 may be an ovularor spherical body sized to couple conformable occluder 300 to a cell ofa prosthetic heart valve. Specifically, disk 330 may be sized largerthan a cell 162 of stent 102 such that it is incapable of passingthrough the cell (see FIG. 1). Disk 330 may be formed of the samematerial as body 310 or from a different material. For example, disk 330may be formed of a braided nitinol mesh or other shape-memory mesh. Itis also contemplated that disk 330 may be constructed from abio-compatible polymer material. Disk 330 may include a lip (not shown)having a greater cross-sectional dimension than disk 330. Femalecomponent 335 connected to disk 330 at trailing end 304 may be used tocouple conformable occluder 300 to a delivery device to position anddeliver conformable occluder 300. Female component 335 may include aninternally threaded screw attachment, a ring, or any other suitablemeans for coupling with a delivery device.

In one example, as shown in FIG. 3C, body 310′ may be hollow and may beat least partially filled with filler 345 of a fabric or fibers ofmaterials that are intertwined within the mesh of conformable occluder300′ to assist with sealing, occlusion and healing. For example, body310′ may include filler 345 of polyester threads or polyester fabric, aswell as any suitable fiber material to increase density and/or promotetissue growth. Filler 345 may also be in the form of a foam material,such as a closed cell sponge. The density of body 310′ may be such thatit impedes the flow of blood through it. Inclusion of filler 345 in body310′ may speed occlusion time for conformable occluder 300′.

In an alternative embodiment, shown in FIG. 3D, occluder 300″ hasleading end 302 and trailing end 304, and may generally include body 310extending from leading end 302 to trailing end 304. As seen in FIG. 3D,occluder 300″ includes first fastener 320 at leading end 302. Instead ofa disk on the opposite end (see disk 330 in FIGS. 3A-3C), occluder 300″includes second fastener 320′ disposed near trialing end 304. In thisembodiment, occluder 300″ may be coupled to select struts 160 of stent102 via first and second fasteners 320,320′ without the need for disk330.

FIGS. 4A-F illustrate the steps used to insert conformable occluder 300(or conformable occluder 300′ or conformable occluder 300″) to sealheart valve 100 within native valve annulus 250. As seen in FIG. 4A,heart valve 100 has been implanted in a patient with annulus portion 140thereof positioned in native valve annulus 250. Gap G may be formedbetween heart valve 100 and native valve annulus 250 to one side ofheart valve 100.

As an initial step to seal gap G, conformable occluder 300 may bedisposed within delivery system 400 (FIG. 4A) in a collapsed condition,such as the stretched or elongated configuration shown in FIG. 3B.Delivery system 400 may include outer sheath 410 and inner wire 420having male component 425. Male component 425 may include a conventionalscrew attachment, a terminal hook or other suitable structure for matingwith female component 335. Male component 425 is configured to couplewith female component 335 of conformable occluder 300 (elements shownuncoupled in FIG. 4F). Outer sheath 410 is slidable relative to innerwire 420. Delivery system 400 may be inserted into the patient andadvanced toward the implanted heart valve 100 in the direction of arrowX. As it reaches heart valve 100, delivery system 400 may be advancedinto the heart valve 100 at aortic end 132 and out therefrom throughcell 162 b in transition section 141 (shown in FIG. 4A). Delivery system400 may then be further advanced through gap G toward annulus end 140 ofimplanted heart valve 100, as shown in FIG. 4B. If heart valve 100 ordelivery system 400 includes echogenic materials, such materials may beused to guide delivery system 400 to the appropriate position using theassistance of three-dimensional echocaradiography to visualize heartvalve 100 within the patient.

Once delivery system 400 has reached the desired site of sealing (e.g.,gap G) as shown in FIG. 4C, outer sheath 410 may be retracted slightlyin the direction of arrow R (toward the trailing end of delivery system400) to expose fastener 320 and a portion of body 310 (shown in FIG.4D). Conformable occluder 300 remains coupled to inner wire 420 at thisstage and trailing edge 304 of occluder 300 remains housed withindelivery system 400.

Delivery system 400 may be manipulated by gently twisting and/or tiltingdelivery system 400 to position fastener 320 over the apex of cell 162 aat annulus end 130 of heart valve 100. Once fastener 320 has latchedonto or been looped around the apex of cell 162 a, outer sheath 410 maybe further retracted in the direction of arrow R to expose body 310 ofconformable occluder 300. As outer sheath 410 is further retracted, moreof occluder body 310 is exposed and occluder 300 expands within the gapG between heart valve 100 and native valve annulus 250 (FIGS. 4D and4E). As seen in FIGS. 4D-4F, body 310 is positioned parallel to annulussection 140 and transition section 141. In this intermediate stage ofdeployment, body 310 has expanded to its relaxed state and contacted thewalls of native valve annulus 250, and substantially fills gap G.

Outer sheath 410 may then be fully retracted to expose disk 330 andallow it to expand near cell 162 b. In the depicted embodiment, disk 330is located on the interior of heart valve 100, although in otherembodiments, disk 330 is located on the exterior of heart valve 100. Ineither instance, disk 330 is spaced away from valve assembly 104 so asnot to impede the normal function of leaflets 178. Disk 330 then expandsto a size small enough to project partially out of or into cell 162 b,but remains too large to pass through that cell. The interference ofdisk 330 with cell 162 b creates a second attachment region forconformable occluder 300. Thus, conformable occluder 300 is stretchedbetween the two attachment regions, the interference between disk 330and cell 162 b and the connection between fastener 320 and cell 162 a.Fastener 320 prevents occluder 300 from migrating into the aorta, whiledisc 330 prevents occluder 300 from migrating back into the heart.Alternatively, in embodiments having two fasteners instead of disk 330,such as that shown in FIG. 3D, first fastener 320 may be coupled to theapex of cell 162 a, while second fastener 320′ may be likewise coupledover the apex of a cell at aortic end 132 of stent 100.

Male component 425 may be disconnected from female component 335 bymanipulating (e.g., rotating) wire 420. Alternatively, inner wire 420may comprise a suture tied to female component 335, and the suture maybe simply cut to release conformable occluder 300 from delivery system400. In another example, the male and female components may be threadedand delivery system 400 may be twisted relative to occluder 300 todecouple the two from one another. Accordingly, many mating solutionsbetween delivery system 400 and occluder 300 would serve the intendedpurpose for deployment of occluder 300. FIG. 4F illustrates heart valve100 in its fully expanded state with conformable occluder 300 fullyfilling the gap G between heart valve 100 and native valve annulus 250.Delivery system 400 may then be withdrawn in the direction of arrow Rand removed from the patient, leaving conformable occluder 300 in placeto seal valve 100 within native valve annulus 250.

FIG. 5 is a highly schematic cross-sectional view showing conformableoccluder 300 in its relaxed state with body 310 fully radially expandedto fill crescent-shaped gap 200 shown in FIG. 2. The mesh of conformableoccluder 300 may be capable of promoting tissue growth between heartvalve 100 and native valve annulus 250. For example, conformableoccluder 300 may be treated with a biological or chemical agent topromote tissue growth on the conformable occluder, further sealing theheart valve within the native valve annulus. Alternatively, conformableoccluder 300 may be sufficiently dense through the use of polyesterfibers or polyester fabric to adequately seal the heart valve withoutthe need for major tissue growth throughout gap G. Occluder 300 may alsobe double-layered and/or may include tighter braiding to more quicklyocclude the space between heart valve 100 and native valve annulus 250.When conformable occluder 300 is functioning properly, heart valve 100will be adequately sealed within native valve annulus 250 so that bloodflows through valve assembly 104 and leaflets 178, while limiting or atleast reducing blood flow through any gaps formed between heart valve100 and native valve annulus 250.

FIG. 6A illustrates another embodiment of conformable occluder 600.Conformable occluder 600 extends between leading end 602 and trailingend 604, and may generally include a tubular body 610 and disk 630. Disk630 includes an enlarged outer rim 632 and is coupled to connector 635for mating with a delivery system (not shown). As seen in FIG. 6A,reduced diameter neck portion 640 connects body 610 to disk 630. Afastener (not shown) may be attached to joint 650 at leading end 602 toconnect occluder 600 to the apex of a cell 162 as described above withreference to FIGS. 4A-4F.

FIGS. 6B-D are a side view, and top and bottom end views illustratingthe use of occluder 600. Specifically, FIG. 6B shows a side view of thesystem, while FIG. 6C illustrates a top view (e.g., as seen from aorticend 132 of stent 102) and FIG. 6D illustrates a bottom view (e.g., asseen from annulus end 130 of stent 102). In these figures, container 670approximates the native valve annulus and stent 102 is disposed thereinto simulate a prosthetic heart valve 100. A valve assembly is not shownattached to stent 102 for the sake of clarity. As seen in FIGS. 6B-D,occluder 600 is coupled to stent 102 and shown to fill a gap betweenstent 102 and the native valve annulus, approximated by the walls ofcontainer 670. Specifically, disk 630 is shown disposed within theinterior of stent 102 (FIG. 6C) and body 610 is disposed outside ofstent 102 (FIG. 6D). Though a fastener is not shown, it will beunderstood that a fastener may attach to joint 650 and couple leadingend 602 of occluder 600 to the apex of a cell at annulus end 130 ofstent 102. Occluder 600 may be delivered and positioned in a mannersimilar to that described above with reference to FIGS. 4A-F.

FIG. 7A illustrates another embodiment of conformable occluder 700.Conformable occluder 700 extends between leading end 702 and trailingend 704, and may generally include a body 710 formed of two bodysegments 712,712′, and disk 730. Though occluder 700 is shown having twosegments 712,712′, it will be understood that three or more segments maybe employed in constructing occluder 700. In some instances, it may behelpful to use multiple segments 712,712′ as opposed to a single unitarybody to improve occlusion. For example, first segment 712 may expand toa small radius, while second segment 712′ may expand to a larger radiusto accommodate a non-uniform native valve annulus and fill multiple gapsat varying longitudinal extents.

Disk 730 includes an enlarged outer rim 732 and is coupled to connector735 for mating with a delivery system (not shown). As seen in FIG. 7A,two reduced diameter neck portions 740,740′ connect disk 730 to firstsegment 712, and first segment 712 to second segment 712′, respectively.A fastener (not shown) may be attached to joint 750 at leading end 702to connect occluder 700 to the apex of a cell 162 as described abovewith reference to FIGS. 4A-4F.

FIGS. 7B-D are a side view, and top and bottom end views illustratingthe use of occluder 700 within a container 770 approximating the nativevalve annulus as described above with reference to FIGS. 6B-6D. As seenin FIGS. 7B-D, occluder 700 is coupled to stent 102 and shown to fill agap between stent 102 and the native valve annulus, approximated by thewalls of container 770. It will be understood that the patient anatomyis rarely perfectly cylindrical and that occluder 700 may contour tocrescent or serpentine cavities. Specifically, disk 730 is showndisposed within the interior of stent 102 (FIG. 6C) and segments712,712′ are disposed outside of stent 102 (FIG. 6D). Though a fasteneris not shown, it will be understood that a fastener may attach to joint750 to couple leading end 702 of occluder 700 to the apex of a cell atannulus end 130 of stent 102. Occluder 700 may be delivered andpositioned in a manner similar to that described above with reference toFIGS. 4A-F.

FIGS. 8A-D illustrate several additional embodiments of conformableoccluders 800 intended to fill irregularities between a heart valve anda native valve annulus. Occluders 800 may include any of the features ofthe aforementioned embodiments and be formed of like materials. In oneembodiment shown in FIG. 8A, conformable occluder 800A has a leading end802A and a trailing end 804A, and may generally include an elongatedballoon-like body 810A extending between leading end 802A and trailingend 804A.

Body 810A may be a metallic structure as described above. Alternatively,body 810A may be formed of any suitable flexible material havingin-growth properties, such as shape memory foams or fabrics includingpolyester and polyethylene terephthalate (PETE), commonly referred to bythe brand name DACRON®. Such materials may be impregnated with collagento improve sealing. Biocompatible or biodegradable materials may also beused to form body 810A such patient tissue or polymers such as polyvinylalcohol (PVA), urethane, silicone and combinations of same orcellulose-based material, which do not have an adverse effect on theprosthetic and/or the native anatomy.

Body 810A may be formed of a compressible material that is collapsed foreasier delivery into the patient and re-expanded after delivery toocclude gaps between a prosthetic heart valve and the native valveannulus to one side of the valve. Body 810A may be hollow andballoon-like, and may further include one or more ports 820A incommunication with the interior of body 810A for filling body 810A witha filler F, as will be described in greater detail below with referenceto FIG. 10. For ease of filling, port 820A may be disposed near trailingend 804A.

In a variation shown in FIG. 8B, occluder 800B includes leading end802B, trailing end 804B and body 810B extending between leading end 802Band trailing end 804B. Body 810B may include a filling port 820B neartrailing end 804B. Body 810B may be formed of material similar to thatof body 810A but may be shaped as a triangular prism.

In a third variation (FIG. 8C), occluder 800C includes leading end 802C,trailing end 804C and body 810C extending between leading end 802C andtrailing end 804C. Body 810C may include a filling port 820C neartrailing end 804C. Body 810C may be accordion-like and include a numberof bellows 830C which fold such that body 810C axially collapses onitself to form body 810C′. Moreover, when bellows 830C are unevenlyspaced at two sides of the body, body 810C may be bent as illustrated bybent body 810C″ to move and comply with the patient's anatomy for bettersealing. In this example, body 810C may be formed of any of thematerials discussed above and may also be formed of expandable coils(e.g., platinum coils).

In yet another variation (FIG. 8D), occluder 800D extends betweenleading end 802D and trailing end 804D and includes body 810D havingfilling port 820D near trailing end 804D. Body 810D is substantiallycrescent-shaped and includes a curvature C that complements thecurvature of an adjacent heart valve. Moreover, in some variations ofthe embodiments of FIGS. 8A-D, body 810 may be formed of a shape-memorymaterial that returns to a predetermined shape (e.g., tubular,accordion-like, crescent, etc.) after delivery.

FIG. 9 is a highly schematic cross-sectional view showing conformableoccluders 800A-C fully radially expanded to fill multiple gaps betweennative valve annulus 250 and heart valve 100. The material ofconformable occluders 800A-C may be capable of promoting tissue growthbetween heart valve 100 and native valve annulus 250. For example,conformable occluders 800A-C may be treated with a biological orchemical agent to promote tissue growth on the conformable occluder,further sealing the heart valve within the native valve annulus. Whenconformable occluders 800A-C functioning properly, heart valve 100 willbe adequately sealed within native valve annulus 250 so that blood flowsthrough valve assembly 104 and leaflets 178, while limiting or at leastreducing blood flow through any gaps formed between heart valve 100 andnative valve annulus 250.

As briefly indicated, occluders 800 may be supplied with a filler. FIG.10 illustrates the process of filling conformable occluder 1000, whichhas a leading end 1002 and a trailing end 1004, and generally includesan elongated balloon-like body 1010 extending between leading end 1002and trailing end 1004. Port 1020 at trailing end 1004 has been coupledto filling tube 1022 to allow hollow body 1010 to be at least partiallyfilled with filler F, which may be a gas or a liquid, such as water orsaline. Filler F may also be introduced to body 1010 either prior to orafter delivery to a desired location and may include a suitable polymera foam, sponge, collagen, polyester threads or polyester fabric, ahydrophilic material or other suitable material that may be compressed.If a liquid or gas is used, body 1010 may include an outer leak-proofcoating 1028 or may include a tight weave of a braided material toencapsulate the filler material.

FIGS. 11-18 illustrate several techniques for fixing occluders in placebetween a heart valve and a native valve leaflet. Though these figuresillustrate occluders being delivered transapically, it will beunderstood that transfemoral, transseptal, transaortic, transradial,transsubclavian and other approaches may also be used. In FIG. 11,occluder 1100 is disposed between heart valve 100 and native valveleaflet 500. Occluder 1100 extends between leading end 1102 and trailingend 1104 and includes body 1110 having port 1120 for filling body 1110via filling tube 1122. Occluder 1100 further includes anchor 1130attached to body 1110 via cord 1132. Anchor 1130 may include one or moresharp ends 1135 for piercing through native valve leaflets 500. Onceanchor 1130 has passed through native valve leaflet 500, occluder 1100is effectively affixed to native valve leaflet 500 and secured in placebetween heart valve 100 and native valve leaflet 500. In one variationof this embodiment, anchor 1130 may be configured to secure occluder1100 to heart valve 100 by being fastened to select cells of stent 102.

In a second embodiment, velcro-like elements secure the occluder inplace between heart valve 100 and native valve leaflet 500 (FIG. 12).Occluder 1200 extends between leading end 1202 and trailing end 1204 andincludes body 1210 having port 1220 for filling body 1210 via fillingtube 1222. Occluder 1200 further includes a plurality of hooks 1240 onthe surface of body 1210 configured and arranged to mate withperforations 1242 of porous cuff 176′ of heart valve 100. Hooks 1240 mayfurther be configured to grab onto native valve leaflet 500. As shown,hooks 1240 may be downwardly disposed (e.g., point toward trailing end1204 of body 1210) and thus prevent occluder 1200 from migrating intothe ventricle. Alternatively, hooks 1240 may be upwardly disposed toprevent occluder 1200 from being upwardly displaced into the aorta or aportion of hooks 1240 may be disposed in each orientation to secure theoccluder and prevent movement in both directions.

In a third embodiment, a clasp secures the occluder in place betweenheart valve 100 and native valve leaflet 500 (FIG. 13). Occluder 1300extends between leading end 1302 and trailing end 1304 and includes body1310 having port 1320 for filling body 1310 via filling tube 1322.Occluder 1300 further includes a curved clasp 1340 on the surface ofbody 1310 near leading end 1302 configured and arranged to cup overnative valve leaflets 500. Clasp 1340 may be formed of a suitable metalor polymer. In one variation, shown in dashed lines, clasp 1340′ iscurved over native valve leaflets 500 and includes a sharp edge 1342that pierces into native valve leaflet 500 to secure occluder 1300 inplace. The fact that clasp 1340 curves over the free end of native valveleaflet 500 prevents occluder 1300 from migrating into the ventricle.

In a fourth embodiment, the occluder is secured between heart valve 100and native valve leaflet 500 via an anchoring ring and a tether (FIG.14). Occluder 1400 extends between leading end 1402 and trailing end1404 and includes body 1410 having port 1420 for filling body 1410 viafilling tube 1422. Occluder 1400 further includes tether 1440 having afirst end 1442 attached to body 1410 near leading end 1402 and a secondend 1444 attached to anchoring ring 1450. Tether 1440 may be formed of asuture, cord or any suitable biocompatible thread. Anchoring ring 1450may be formed of a collapsible and expandable metal similar to that ofstent 102 of heart valve 100 and dimensioned to be disposed above heartvalve 100 (e.g., closer to the aorta than heart valve 100). By securinganchoring ring 1450 in place and securing occluder 1400 to the anchoringring, occluder 1400 is prevented from migrating into a ventricle.

In a fifth embodiment, the occluder is secured between heart valve 100and native valve leaflet 500 via barbs (FIG. 15). Occluder 1500 extendsbetween leading end 1502 and trailing end 1504 and includes body 1510having port 1520 for filling body 1510 via filling tube 1522. Occluder1500 further includes a plurality of barbs 1540 on body 1510. Barbs 1540may be circumferentially disposed about body 1510 and configured andarranged to couple body 1510 to heart valve 100 and to native valveleaflet 500. Barbs 1540 may be angled or shaped to prevent occluder 1500from migrating toward the ventricle. Certain barbs 1540′ may beoppositely angled or shaped to prevent occluder 1500 from beingdisplaced toward the aorta.

A sixth embodiment utilizes magnets to secure the occluder between heartvalve 100 and native valve leaflet 500 (FIG. 16). Occluder 1600 extendsbetween leading end 1602 and trailing end 1604 and includes body 1610having port 1620 for filling body 1610 via filling tube 1622. Occluder1600 includes a plurality of longitudinal magnetic strips 1640circumferentially spaced about body 1610 and configured to couple tocomplementary magnetic strips 1650 attached to heart valve 100.Alternatively, stent 102 may be magnetized or made from a materialcapable of being magnetically coupled to strips 1640 of occluder 1600.It will be understood that in some variations, body 1610 and stent 102may themselves be sufficiently magnetized so as to couple togetherwithout the need for intermediate elements.

In a seventh embodiment, a staple may be used to couple body 1710 ofoccluder 1700 to heart valve 100 and/or to native valve leaflet 500(FIG. 17). Staple 1740 may be formed of a metal or other suitablematerial. Staple 1740 may be separable from body 1710 and deployed afterimplantation of heart valve 100 and occluder 1700. It will be understoodthat multiple staples may be used around and/or along the periphery ofbody 1710.

An eighth embodiment utilizes locking features to secure the occluderbetween heart valve 100 and native valve leaflet 500 (FIG. 18). Occluder1800 extends between leading end 1802 and trailing end 1804 and includesbody 1810 having port 1820 for filling body 1810 via filling tube 1822.Occluder 1800 includes a bit 1840 protruding from body 1810. In oneexample, bit 1840 is formed as a substantially spherical body, though itwill be understood that one of ordinary skill in the art may utilizeother shapes for bit 1840. Heart valve 100 may include receiver 1850having a narrow vertical slot 1854 for locking bit 1840 in place. Anenlarged opening 1852 is sized to receive bit 1840 and to guide bit 1840into narrow slot 1854. Bit 1840 may be sized to pass through enlargedopening 1852 but not narrow slot 1854. In operation, bit 1840 isincapable of decoupling from receiver 1850 at the ends of narrow slot1854. Thus, when occluder 1800 moves upward toward the aorta or downwardtoward the ventricle, occluder 1800 will remain secured to heart valve100. It will be understood that modifications may be made to have thesame effect. For example, various male and female components as known inthe art may be used instead of bit 1840 and receiver 1850 to coupleheart valve 100 and occluder 1800.

While the inventions herein have been described for use in connectionwith heart valve stents having a particular shape, the stent could havedifferent shapes, such as a flared or conical annulus section, aless-bulbous aortic section, and the like, and a differently shapedtransition section. Additionally, though the conformable occluders havebeen described in connection with expandable transcatheter aortic valvereplacement, they may also be used in connection with surgical valves,sutureless valves and other devices in which it is desirable to create aseal between the periphery of the device and the adjacent body tissue.Additionally, though the deployment of the occluder has been describedwith fastener 320 deployed first, followed by body 310 and finally disk330, it will be understood that, through a different delivery approach,such as, for example, a transapical route, disk 330 may be deployedfirst, followed by body 310 and then fastener 320. Radiopaque elementsmay be included on body 310, fastener 320, disk 330 or any portion of anoccluder to aid in guiding and placement.

It will also be understood that while the preceding disclosure hasillustrated the use of a single occluder to fill gaps to one side of aprosthetic heart valve, it will be understood that multiple occludersmay be deployed around the perimeter of a heart valve. Such occludersmay be delivered successively to each gap formed between the prostheticheart valve and the native valve annulus. Where multiple occluders areused, they may be of different sizes to accommodate different size gaps.Conversely, multiple occluders may be delivered simultaneously using alarge single outer sheath having two or more male components or otherconnectors. Additionally, multiple occluders may be simultaneouslydeployed by using multiple delivery systems each having a male componentor other connector. Moreover, though the securing features have beendescribed in one manner, it will be understood that where the occludersare delivered through a different approach, securing features may bemoved from the leading end to the trailing end of the occluder and viceversa.

Moreover, although the disclosure herein has been described withreference to particular embodiments, it is to be understood that theseembodiments are merely illustrative of the principles and applicationsof the present disclosure. It is therefore to be understood thatnumerous modifications may be made to the illustrative embodiments andthat other arrangements may be devised without departing from the spiritand scope of the present disclosure as defined by the appended claims.

In some embodiments, an occluder device for occluding a gap between amedical device and adjacent body tissue includes a conformable bodyhaving a hollow interior, a leading end and a trailing end; and a portdisposed at the trailing end of the body and in fluid communication withthe interior of the body.

In some examples, the body may be an elongated balloon-like structure;and/or the body may be a triangular prism; and/or the body may beaccordion-like and includes a plurality of bellows that expand andcontract to change the shape of the body; and/or the medical device maybe a prosthetic heart valve having a collapsible and expandable stentforming cells, and a valve assembly disposed in the stent forcontrolling the flow of blood through the stent and wherein the body iscrescent-shaped and has a curvature that complements a curvature of theheart valve; and/or the occluder device may further include a source ofin fluid communication with the port; and/or the occluder device mayfurther include a source of polymeric filler in fluid communication withthe port.

In some embodiments, an occluder device for occluding a gap between amedical device and adjacent body tissue includes a conformable bodyhaving a leading end and a trailing end; and a securing featurecoupleable to the conformable body and at least one of the medicaldevice and the adjacent body tissue.

In some examples, the securing feature may include an anchor and a cordfor coupling the anchor to the body, the anchor being configured tocouple to at least one of the medical device and the adjacent bodytissue; and/or the anchor may have at least one sharp end for piercingthe adjacent body tissue; and/or the securing feature may include aplurality of velcro-like hooks disposed on the body and the medicaldevice includes a cuff having perforations coupleable to the pluralityof hooks; and/or the securing feature may include a clasp coupled to theleading end of the body, the clasp being configured to cup over theadjacent body tissue; and/or the clasp may have a sharp end for piercingthe adjacent body tissue and/or the securing feature may include atether having a first end secured to the leading end of the body and asecond end secured to an anchoring ring, the anchoring ring being spacedaway from the medical device; and/or the securing feature may include aplurality of barbs disposed on the body; and/or the securing feature mayinclude a first magnetic element on the occluder device and a secondmagnetic element on the medical device, the first magnetic element andthe second magnetic element being configured to attract one another tosecure the occluder device to the medical device; and/or the securingfeature may include a staple for securing the body to the adjacent bodytissue; and/or the securing feature may include a locking featureincluding a bit protruding from the body of the occluder device and areceiver coupled to the medical device and having an aperture sized toreceive the bit; and/or the receiver may include a narrow slot with anenlarged opening therein, the bit being sized to pass through theenlarged opening but not the narrow slot.

It will be appreciated that the various dependent claims and thefeatures set forth therein can be combined in different ways thanpresented in the initial claims. It will also be appreciated that thefeatures described in connection with individual embodiments may beshared with others of the described embodiments.

The invention claimed is:
 1. A system for replacing native valvefunction, the system comprising: a prosthetic heart valve having acollapsible and expandable stent, the stent having a plurality ofsections, and a valve assembly disposed in the stent; an occluder havinga leading end and a trailing end, the trailing end disposed adjacent aninflow end of the stent, the occluder configured to be disposed betweenthe prosthetic heart valve and adjacent body tissue for occluding a gapbetween the prosthetic heart valve and the adjacent body tissue, whereinthe occluder includes securing features disposed on and projecting fromthe occluder, the securing features configured to couple the occluder tothe prosthetic heart valve and the adjacent body tissue, and wherein theoccluder comprises a fillable chamber with a delivery, pre-deploymentconfiguration and a final, post-deployment configuration, the occluderin both the pre-deployment and post-deployment configurations includinga port disposed at the trailing end and in fluid communication with thefillable chamber.
 2. The system of claim 1, wherein the occluderlongitudinally extends in a lengthwise direction toward an outflow endof the stent.
 3. The system of claim 1, further comprising a source ofgas in fluid communication with the port.
 4. The system of claim 1,further comprising a source of polymeric filler in fluid communicationwith the port.
 5. The system of claim 1, wherein the fillable chamber ofthe occluder has an outer coating configured to prevent leakage of aliquid or a gas.
 6. The system of claim 1, wherein the plurality ofsections of the stent includes an annulus section, a transition section,and an aortic section.
 7. The system of claim 1, wherein the occluderincludes at least one of a metallic mesh or a shape-memory material. 8.The system of claim 1, wherein the securing features includes aplurality of hooks disposed on the occluder and the prosthetic valveincludes a cuff having a plurality of perforations, the hooks of theoccluder being coupleable to the perforations of the cuff.
 9. The systemof claim 1, wherein the securing features on the occluder includes afirst magnetic element configured to attract to a second magneticelement disposed on the prosthetic heart valve to secure the occluder tothe prosthetic heart valve.
 10. The system of claim 1, wherein thesecuring features of the occluder includes barbs shaped having a firstshape to prevent the occluder from migrating toward the ventricle andbarbs having an opposite second shape to prevent the occluder frommigrating toward the aorta.
 11. A system for replacing native valvefunction, the system comprising: a prosthetic heart valve having acollapsible and expandable stent, the stent having a plurality ofsections, and a valve assembly disposed in the stent; an occluder havinga leading end and a trailing end disposed adjacent an inflow end of thestent, the occluder including a port disposed at the trailing end, theoccluder configured to be disposed between the prosthetic heart valveand adjacent body tissue for occluding a gap between the prostheticheart valve and the adjacent body tissue, wherein the occluder includessecuring features disposed on and projecting from the occluder, thesecuring features configured to couple the occluder to the prostheticheart valve and the adjacent body tissue.
 12. The system of claim 11,wherein the occluder longitudinally extends in a lengthwise directiontoward an outflow end of the stent.
 13. The system of claim 11, whereinthe occluder comprises a fillable chamber with a delivery,pre-deployment configuration and a final, post-deployment configuration,the occluder in both the pre-deployment and post-deploymentconfigurations including the port in fluid communication with thefillable chamber.
 14. The system of claim 11, further comprising asource of gas in fluid communication with the port.
 15. The system ofclaim 11, further comprising a source of polymeric filler in fluidcommunication with the port.
 16. The system of claim 11, wherein theplurality of sections of the stent includes an annulus section, atransition section, and an aortic section.
 17. The system of claim 11,wherein the securing features includes a plurality of hooks disposed onthe occluder and the prosthetic valve includes a cuff having a pluralityof perforations, the hooks of the occluder being coupleable to theperforations of the cuff.
 18. The system of claim 11, wherein thesecuring features on the occluder includes a first magnetic elementconfigured to attract to a second magnetic element disposed on theprosthetic heart valve to secure the occluder to the prosthetic heartvalve.
 19. The system of claim 11, wherein the securing features of theoccluder includes barbs shaped having a first shape to prevent theoccluder from migrating toward the ventricle and barbs having anopposite second shape to prevent the occluder from migrating toward theaorta.